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Session 10 Track 3: Real-World Regulatory Experiences with Clinical/Commercial Oligonucleotides
Session Chair(s)
Firoz Antia, PhD
Vice President, Oligonucleotide and Small Molecule CMC, Denali Therapeutics, United States
Recent filings of oligonucleotides have come with interesting challenges for regulators and industry alike. Hot topics and learnings from recent filings will be discussed with two talks from industry, followed by a panel discussion with regulatory agency and industrial participants.
Learning Objective : At the conclusion of this session, participants should be able to: - Identify key regulatory challenges associated with modern oligonucleotide therapeutics
- Recognize benefits and concerns with oligonucleotide filing strategies
- Compare perspectives of US and ex-US regulators as well as industrial practitioners on the above topics
Speaker(s)
Representative Invited
Senior Director, Regulatory Affairs CMC, Vertex Pharmaceuticals, United States
Speaker
Jennifer A. Franklin
Executive Director, CMC RegulatoryAffairs, Ionis Pharmaceuticals, Inc., United States
Speaker